Clinical Core

目前，对于治疗HIV相关神经认知障碍（HAND）的临床试验，还没有统一接受的临床、神经影像学或实验室结果测量方法。本核心的目标是：1)提供必要的资源，以继续对具有良好特征的HIV+和人口统计学匹配的HIV-个体进行临床队列研究，以评估新的结果测量和替代标记物，用于HAND的临床试验；2)与其他NIMH中心或参与神经艾滋病治疗工作的其他受资助的ipcp联系，以帮助确定潜在的候选药物；3)为设计和开展小型试点研究提供必要的资源，以评估治疗HAND的潜在新化合物；4)维护数据基础设施，以便有效查询临床和实验室数据；5)为涉及中心资助资源的研究提供统计支持；6)为正在进行的神经艾滋病试验联盟提供联系资源。临床结果核心为150名HIV+和50名HIV-个体的队列提供支持，用于评估神经认知和新功能评估。

There currently are no uniformly accepted clinical, neuroimaging, or laboratory outcome measures for clinical trials for the treatment of HIV associated neurocognitive disorders (HAND). The goals and objectives of this Core are: 1) to provide the resources necessary to continue a clinical cohort of well-characterized HIV+ and demographically-matched HIV- individuals for studies evaluating new outcome measures and surrogate markers for clinical trials of HAND, 2) to liaise with other NIMH Centers or other funded IPCPs involved in NeuroAIDs therapeutic work to help identify potential candidate agents, 3) to provide the resources necessary to design and conduct small pilot studies to evaluate potential novel compounds to treat HAND, 4) to maintain a data infrastructure to allow for efficient querying of clinical and laboratory data, 5) to provide statistical support for studies involving the Center Grant resources, 6) to provide a resource for linkage with ongoing Neuro-AIDS trial consortia. The Clinical Outcomes Core provides support for a cohort of 150 HIV+ and 50 HIV- individuals which is used to evaluate both neurocognitive and novel functional assessments. Stored CSF and blood specimens from cohort participants are used to validate surrogate markers. Participants with a well characterized HAND stage from the Clinical Outcomes Cohort are used for developmental projects. The Core also evaluates safety, tolerability, and efficacy outcome measures for new compounds for the treatment of HAND. Thus, the Core provides a service to develop improved outcome measures for use in clinical trials, and obtains preliminary data for candidate drugs of safety and tolerability. The Core will also obtain data to determine the sample size needed for larger, confirmatory studies of efficacy.